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FDA Drug Application 020010 by MERCK SHARP DOHME

Application Number020010
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation; New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/8/2000N17000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20010ltr.pdf 12/8/2000
AP012/8/2000N18000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20010lbl.pdf 12/8/2000
AP012/8/2000N10149000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20010_Lotrisone.cfm 9/8/2004
AP01/10/2002SCS       
AP04/4/2002SCS       
AP012/17/2002SLR3489003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20010slr003ltr.pdf 12/17/2002
AP012/17/2002SLR4877003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20010slr003_Lotrisone_lbl.pdf 4/4/2003
AP03/27/2003SLR4653005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20010slr005_lotrisone_lbl.pdf 3/28/2003
AP03/27/2003SLR5276005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20010slr005ltr.pdf 4/15/2003
AP04/24/2006SLR13992011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020010s011LTR.pdf 4/25/2006
AP01/25/2008SLR18970015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020010s015lbl.pdf 1/30/2008
AP01/25/2008SLR19244015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020010s015ltr.pdf 2/21/2008
AP012/18/2008SLR21408020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020010s020ltr.pdf 12/24/2008
AP05/11/2009SLR22565021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020010s021lbl.pdf 5/13/2009
AP05/11/2009SLR22566021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020010s021ltr.pdf 5/13/2009




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